Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles (sildenafil)
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Purpose
The target of this study was an estimate the result of sildenafil on ultrasonographic endometrial thickness, endometrial pattern investigation estrogen level on the day of progesterone administration, Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles .
| Condition | Intervention | Phase |
|---|---|---|
|
Endometrial Preparation Frozen Embryo Transfer |
Drug: Sildenafil Drug: estradiol valerat |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Effect of Adding Sildenafil to Protocol of Endometrial Preparation in Outcome of Frozen-thawed Embryo Transfer Cycles |
- estimate the result of sildenafil on ultrasonographic endometrial thickness [ Time Frame: between 2009-2011 (up to 2 years) ] [ Designated as safety issue: Yes ]
Assays:
Day 13 of menstrual cycle endometrial thickness estimated with Transvaginal ultrasonographic(arranged in a series every other day), evaluations were performed by a single investigator, If the endometrial thickness is more than 8mm progesterone injected 100 mg intramuscular and Estrogen, progesterone and lh measured in blood sample then after three days embryo transferred.
- estimate the result of sildenafil on Implantation rate and chemical pregnancy rate in frozen embryo transfer cycles . [ Time Frame: between 2009-2011 (up to 2 years) ] [ Designated as safety issue: Yes ]Implantation rate was higher in sildenafil Group but not significant chemical pregnancy rates were higher in sildenafil Group but not significant.
| Enrollment: | 2 |
| Study Start Date: | September 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: sildenafil
One of two group to prepare the endometrium give estradiol by step up method with menstruation. From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily. |
Drug: Sildenafil
sildenafil tablets(50 mg) daily
|
|
Experimental: Sildenafil and estradiol valerat
One of two group to prepare the endometrium give estradiol by step up method with menstruation. From first to fourth day of menstrual cycle, estradiol valerat tablet 2 mg daily From Fifth to eighth day of menstrual cycle, estradiol valerat tablet 4 mg daily From Ninth to twelfth day of menstrual , estradiol valerat tablet 6 mg daily The second group in addition to the above treatment protocol from First day of cycle until day of starting progesterone will be given sildenafil tablets(50 mg) daily. |
Drug: Sildenafil
sildenafil tablets(50 mg) daily
Drug: estradiol valerat
|
Eligibility| Ages Eligible for Study: | 20 Years to 39 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- women > 40 years old,
- history of endocrine disease
- Hysteroscopic surgery
- cardiovascular, renal and liver disease
- hypotension( blood pressure < 90/50)
- history of stroke or myocardial infarction
- use of alcohol or substance
Exclusion Criteria:
A total of 80 patients with antecedent of poor endometrial response and had frozen embryo included in this study all women must to be < 40 years old,
- no history of endocrine disease,
- no Hysteroscopic surgery, had a high quality embryos no cardiovascular,
- renal and liver disease and
- no hypotension (blood pressure < 90/50) or
- history of stroke or myocardial infarction and
- don't use of alcohol or substance Patients with these conditions enter this study and based on randomized tables are divided in two groups.
Contacts and Locations| Iran, Islamic Republic of | |
| Farzaneh Hojjat | |
| Yazd, Iran, Islamic Republic of, 8916878466 | |
| Principal Investigator: | farzaneh hojjat, MD | Department of Obstetrics and Gynecology, Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Science, Bouali Ave. Safaieh, Yazd,Iran. |
More Information
No publications provided
| Responsible Party: | farzaneh hojjat, Farzaneh hojjat MD, Shahid Sadoughi University of Medical Sciences and Health Services |
| ClinicalTrials.gov Identifier: | NCT01668446 History of Changes |
| Other Study ID Numbers: | radvin123, rad123, rad123 |
| Study First Received: | June 24, 2012 |
| Last Updated: | September 11, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Shahid Sadoughi University of Medical Sciences and Health Services:
|
Sildenafil Endometrial thickness Frozen embryo transfer ultrasonographic endometrial thickness |
endometrial pattern Implantation rate chemical pregnancy rate |
Additional relevant MeSH terms:
|
Adenoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Estradiol Polyestradiol phosphate Estradiol valerate Estradiol 3-benzoate Estradiol 17 beta-cypionate Sildenafil Estrogens Hormones Hormones, Hormone Substitutes, and Hormone Antagonists |
Physiological Effects of Drugs Pharmacologic Actions Contraceptive Agents Reproductive Control Agents Therapeutic Uses Contraceptive Agents, Female Vasodilator Agents Cardiovascular Agents Phosphodiesterase 5 Inhibitors Phosphodiesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 21, 2013